Manufacturers of Class I, IIa, IIb and III medical devices must obtain certification demonstrating compliance with the EU Medical Device Directive 93/42/EEC, from a registered notified body before applying the CE mark to products and placing them on the market.
Mercian Surgical’s instruments and medical devices conform to the essential requirements of the EU Medical Directive 93/42/EEC, allowing us to legally place the CE mark on our products. We are annually audited by our respected notified body SGS 1639 to ensure compliance with the applicable standards and directive.
As required by Medical Device Directive 93/42/EEC article 14, paragraph 2 Mercian have appointed Advena Ltd, Tower Business Centre 2nd Flr. Tower Street Swatar, BKR 4013 Malta.
As our EU Authorised Representative, providing a point of contact between Mercian and the national Competent Authorities and Notified Bodies within EU countries. Our related registration certificates can be viewed or downloaded below.
We are registered and regulated by our UK Competent Authority; the MHRA as a manufacturer of medical devices.
We operate a full quality management system which is audited to meet international standard ISO 13485:2016, the world’s most widely recognised quality management system standard for medical devices. Allowing us to continually monitor and improve our company procedures across all operations.
We have also introduced ethical standards across the organisation which are reviewed as part of an independent Labour Standards Assurance System (LSAS) audit and a copy of our LSAS Policy is available for download below.
View our quality certificates
View our EC REP Certificates